A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Active-Reference Study of Gaboxadol in Primary Insomnia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209937

Enrollment

675

Registered

2005-09-21

Start date

2003-01-31

Completion date

2004-06-30

Last updated

2007-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Keywords

Primary insomnia

Brief summary

To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

Detailed description

To compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

Interventions

DRUGGaboxadol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* diagnosis of Primary insomnia

Design outcomes

Primary

Measure	Time frame
Efficacy	—
Safety	—
Tolerability	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026